-
3 weeks ago | 
thefdalawblog.com | JP Ellison |Paul Hyman |Ricardo Carvajal
That’s a play on an old acronym, in service of a point.
-
Nov 18, 2024 | 
saludequitativa.blogspot.com | JP Ellison
-
Nov 17, 2024 | 
thefdalawblog.com | JP Ellison
The word unprecedented has been used a lot in the past two weeks. Perhaps appropriately. Below is some precedent that’s been on this blogger’s mind recently and that may be relevant in the coming days, weeks, and months: Tummino v. Hamburg. Why? The HHS Secretary intervened in an FDA approval decision. The court ruled the agency’s action was arbitrary and capricious and entered a mandatory injunction ordering FDA to make the drug available. Trump v. Hawaii and related cases. Why?
-
Nov 11, 2024 | 
thefdalawblog.com | JP Ellison |Deborah Livornese
On November 8, 2024, FDA issued a proposed order to remove the oral decongestant ingredient phenylephrine (including both phenylephrine hydrochloride and phenylephrine bitartrate) (collectively, PE) from the OTC monograph on the basis of a lack of effectiveness. FDA also noted that it has concluded that no safety signal was identified for oral PE at doses permitted under the monograph.
-
Nov 3, 2024 | 
thefdalawblog.com | Sara W. Koblitz |JP Ellison |John W.M. Claud
Back in July, the United States Supreme Court turned the world of administrative law on its head, adding new layers of judicial oversight to what might have previously been thought of as fairly non-descript Federal agency functions. One of those cases was Loper Bright v. Raimondo, which formally overruled the 40-year precedent under Chevron, under which courts gave agencies deference when interpreting statutory ambiguity.
-
Oct 7, 2024 | 
thefdalawblog.com | Anne Walsh |JP Ellison
It took only 3 months. In June, the Supreme Court ruled that the SEC cannot use its administrative authority to impose civil penalties for securities fraud on the ground that these penalties violate the U.S. Constitution’s Seventh Amendment right to a jury trial. See SEC v Jarkesy, 144 S. Ct. 2117 (2024).
-
Jul 15, 2024 | 
thefdalawblog.com | JP Ellison |John W.M. Claud
The Supreme Court’s recent decision in Loper Bright v. Raimondo has done away with Chevron deference to federal agencies’ interpretation of ambiguous statutes, including the FDA. The decision commands that federal judges must make their own decisions in suits against FDA, considering—but not deferring to—the Agency’s interpretation of ambiguous statutory provisions. Stripping FDA of the key tool of deference, Loper Bright will undoubtedly reinvent the way FDA advocates in federal courts.
-
Jul 8, 2024 | 
thefdalawblog.com | JP Ellison |Riette van Laack |Riëtte van Laack
On Thursday, the 27th of June, the Supreme Court issued its decision in Securities and Exchange Commission v. Jarkesy. The court ruled that the Securities and Exchange Commission (SEC) may not impose fines to penalize securities in its administrative proceedings because that practice violates the Seventh Amendment “right of trial by jury” in all “suits at common law.” This decision likely will impact other federal administrative agencies, including those relevant to our practice.
-
Jul 3, 2024 | 
thefdalawblog.com | John W.M. Claud |JP Ellison
Among the tools that the government has to enforce the FDC Act is the injunctive power granted by Congress in 21 U.S.C. § 332. That statute provides that courts “shall have jurisdiction, for cause shown, to restrain violations” of the FDC Act. Historically, courts have modified, watered down, or altogether eschewed the traditional equitable requirements for an injunction when considering FDA’s request for injunctive relief. The Supreme Court’s decision in Starbucks Corp. v.
-
Sep 29, 2023 | 
thefdalawblog.com | Anne Walsh |JP Ellison
As readers of the FDA Law Blog know, the FDC Act is a strict liability criminal enforcement statute that can impose criminal misdemeanor penalties on a person without any showing of intent. See some of our prior posts, here, here, and here. If committed with an intent to defraud or mislead, an FDC Act violation can become a felony, which carries more significant jail time and financial penalties. See some of those prior posts here and here.
